The advent of recombinant DNA methodology has afforded the opportunity to produce any of a wide range of peptides and proteins. One such protein is human proinsulin. Human proinsulin is useful both as an intermediate in the production of human insulin and as a pharmaceutical agent in its own right in the management of diabetes.
In the recombinant DNA production of human proinsulin, the product customarily is handled in an aqueous solution and is freeze-dried to a non-crystalline powder. A crystalline form of human proinsulin, if available, would afford many advantages in terms of, among others, its storability, formulation strategies, and processes for its isolation and purification.
It is to a novel crystalline form of human proinsulin and to a process for its production that this invention is directed.